Optimizing retention strategies for opioid use disorder pharmacotherapy: The retention phase of the CTN-0100 trial (RDD)
01/2025
Journal Article
Authors:
Shulman, M.;
Meyers-Ohki, S.;
Novo, P.;
Provost, S.;
Ohrtman, K.;
Van Veldhuisen, P. ;
Oden, N.;
Otterstatter, M.;
Bailey, G. L.;
Liu, D.;
Rotrosen, J.;
Weiss, R. D.;
Nunes, E. V.
Pagination:
107816
Journal:
Contemp Clin Trials
PMID:
39842691
URL:
https://www.ncbi.nlm.nih.gov/pubmed/39842691
Keywords:
Automated psychosocial intervention Buprenorphine Naltrexone Opioid use disorder Opioids Treatment
Abstract:
NTRODUCTION AND BACKGROUND: The three medications approved to address OUD are effective in decreasing opioid use and morbidity and mortality; however, their utility is limited by high rates of dropout from treatment. The CTN-0100 trial will develop an evidence base for strategies to improve retention on buprenorphine and extended-release naltrexone. RESEARCH DESIGN AND METHODS: The National Drug Abuse Treatment Clinical Trials Network (CTN) study CTN-0100, "Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy" (RDD), is a multicenter, randomized, non-blinded trial enrolling more than a thousand patients from 18 community-based substance use disorder treatment programs. Participants are adult volunteers seeking to initiate medication treatment for OUD (MOUD). Individuals choose between buprenorphine or extended-release injectable naltrexone. The trial randomizes participants choosing buprenorphine, in a 3 x 2 factorial design, to a medication condition (standard-dose sublingual buprenorphine, high-dose sublingual buprenorphine, or extended-release injectable buprenorphine) and to a behavioral condition (Medical Management or Medical Management plus a digital therapeutic (smartphone) app). Individuals choosing extended-release naltrexone are randomized only to a behavioral condition. Participants receive study medication for 74 weeks and are then followed for a further 24 weeks. The primary outcome is successful retention on MOUD at 26 weeks (six months), with 50- and 74-week retention among the secondary outcomes. DISCUSSION/CONCLUSION: Dropout from treatment is a major barrier to the effectiveness of MOUD. The CTN-0100 study will determine whether strategies such as high dose sublingual or extended-release buprenorphine, or an app-based behavioral intervention improve retention on MOUD. CLINICALTRIALS: gov Identifier: NCT04464980.
